Sharing influenza viruses & access to vaccines and … influenza viruses & access to vaccines and other benefits Pandemic Influenza Preparedness Framework Landmark, innovative public

Sharing influenza viruses & access to vaccines and other benefits

Pandemic Influenza Preparedness Framework

➔ Landmark, innovative public

health arrangement to increase

global preparedness to

respond to pandemic

influenza

➔ Focus is on increasing equity of

access to life saving measures

➔ Brings together Member States,

industry, other key stakeholders,

and WHO

© World Health Organization 2014 2

What is PIP?

Member

States WHO

Industry Other

key

stakeholders

Civil

society

organ-

izations

➔ Two objectives to be pursued on an equal footing:

− Improve sharing of influenza viruses with the potential to

cause a pandemic among humans

− Achieve more predictable, efficient, and equitable

access to benefits arising from the sharing of viruses,

notably vaccines and antiviral medicines


Objectives of PIP Framework

➔ Applies to H5N1 and other influenza viruses

with human pandemic potential

➔ Does not apply to seasonal influenza viruses


Limited framework scope

➔ Virus sharing

➔ Benefit sharing: SMTA 2* & Partnership contribution

➔ Governance & review


Main elements of Framework

* The PIP Framework has two ‘Standard Material Transfer Agreements’ or SMTA.

They are found in Annex 1 and Annex 2, respectively, of the PIP Framework.

SMTA type 1

Applies solely to transfers of PIP Biological Materials (also known as “PIPBM”) among

laboratories within the GISRS network

SMTA type 2

Applies to transfers of PIPBM to entities outside the GISRS network

➔ Member States share ‘influenza

viruses with potential to cause

human pandemic’ through the

Global Influenza Surveillance and

Response System (GISRS), a

WHO-coordinated network of

Public Health labs

➔ GISRS labs use these viruses to

assess the risk of pandemic

influenza & to develop candidate

vaccine viruses


Virus sharing

➔ PIP Framework benefit-sharing system provides: − Equitable access to vaccines

− Surveillance & risk assessment information

− Technical assistance

− Support to strengthen national pandemic influenza response capacities

➔ Two benefit-sharing mechanisms: − SMTA 2: Contracts between WHO and non-GISRS recipients of ‘PIP biological

materials’. Recipients commit to provide real-time access to pandemic supplies

needed for pandemic response (e.g. vaccines, antivirals, diagnostics)

− Partnership Contribution: Annual payments from manufacturers to WHO, used to

strengthen preparedness & response capacities in countries in need (e.g. Lab &

Surveillance, Risk communications, Regulatory capacities)

Benefit sharing


SMTA 2


GISRS

PIP

biological materials1

(PIPBM)

Non-GISRS

recipient of PIPBM

Biotech firms

Pharmaceutical

manufacturers

Research & academic institutions

Influenza

vaccine

manufacturers

Diagnostic

manufacturers

Recipients

assess benefits

to be shared

through WHO

according to

their nature &

capacity SMTA 2

Agreement negotiated

and signed

Preparedness Technical support to strengthen influenza laboratory

and surveillance capacities in developing countries

Licenses to technology relevant to the production of

pandemic related products

Response Donations and/or reserve for purchase by WHO

at affordable prices, of pandemic influenza

vaccine, antiviral medicines, or other pandemic

related products

1 Definition of PIP Biological Materials, PIP Framework, section 4.1

Partnership Contribution


GISRS Manufacturers

use GISRS

Sequence

information

Vaccine virus

Antiviral

susceptibility

assays

Preparedness Lab & surveillance capacity building

Burden of disease studies

Regulatory capacity building

Risk communications

Planning for deployment

Response Pandemic response products and

services including: antiviral medicines;

pandemic vaccines; diagnostic

products; and other pandemic related

products

1 Definition of PIP Biological Materials, PIP Framework, section 4.1

Reagents

Data

Other

70%

30%

Benefit sharing

Partnership

Contribution

(US$ 28 million / year to WHO)

Annual PC vs. One-time SMTA 2


Partnership

Contribution

SMTA 2

Annual PC payments by manufacturers to WHO

SUPPLY COMMITMENTS

Time

Licenses, tech transfer, training, etc.

Pandemic declared.

Vaccines, antivirals,

diagnostics and other

pandemic response

products committed

under SMTA2 become

due.

SMTA 2 signed once between WHO and

non-GISRS recipient of PIPBM.

Activated upon the declaration of a pandemic.

Once signed, signatory has access to any and

all PIPBM needed without need to sign another

SMTA 2.

Equity &

solidarity in

pandemic

response

Year Year Year Year Year Year Year

➔ 3-pillared oversight mechanism − World Health Assembly: oversees implementation

− Director-General: promotes implementation

− Advisory Group:

• Advises Director-General on the use of the Partnership Contribution

• Monitors & assesses implementation of Framework

• Interacts with Industry & other stakeholders

➔ Full Framework review by 2016

Governance & review


➔ Virus sharing

− H5N1 and other viruses

➔ Governance

− Advisory Group established

− Regular interaction with Member States, Industry & other stakeholders

− Review Group - 2016

➔ Benefit sharing

− Partnership Contribution processes established & operating (e.g. questionnaire for

contributor identification; distribution formula; SoPs)

− High Level Partnership Contribution Implementation Plan 2013-2016 &

Gap Analyses approved

− SMTA signed

➔ Communications

− Website, brochure, Q&A doc,

bi-monthly newsletter

Key implementation milestones to date


PC Preparedness Implementation


Area of Work Goals

Laboratory & Surveillance

Improve national ability to detect, monitor and share novel influenza viruses

Burden of Disease

Training and support for burden of influenza estimates to contribute to development of global burden of influenza estimate

Regulatory Capacity-Building

Build national regulatory capacity so that vaccines, diagnostic tests and antiviral medicines for influenza can be deployed quickly

Planning for Deployment

Plan for efficient and equitable deployment of vital supplies for pandemic influenza

Risk Communications

Build national capacity to provide accurate public health information during emergencies

Bringing it all together: Detection to protection


➔ Ramp up implementation: Virus sharing, Partnership Contribution

and SMTA2 negotiations

➔ Improve & increase communications

➔ Prepare for full Framework review in 2016

Next steps


http://www.who.int/influenza/pip/en/

Thank you

谢谢

Merci

Cпасибо

شكرا ً

Gracias

World Health Organization

20 Avenue Appia

1211 Geneva 27

Switzerland

PIP Framework Secretariat

Pandemic and Epidemic Diseases

Health Security

email [email protected]

http://www.who.int/influenza/pip/en/

Documents

Sharing influenza viruses & access to vaccines and … influenza viruses & access to vaccines and other benefits Pandemic Influenza Preparedness Framework Landmark, innovative public